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EXAMINE-Studie zur kardiovaskulären Sicherheit von Alogliptin erreicht primären Endpunkt: keine Erhöhung des kardiovaskulären Risikos bei Risikopatienten mit Typ-2 Diabetes
Date:9/11/2013

mit mittlerem Beobachtungszeitraum von 18 Monaten; Risikoverhältnis 0,96; obere Grenze des Konfidenzintervalls (KI) 1,16. Alogliptin ist ein Dipeptidylpeptidase-4-Inhibitor (DPP-4i) zur Behandlung von Diabetes Typ 2 bei Erwachsenen.

„Wir brauchen sicherere Diabetestherapien für Patienten mit einem erhöhten Risiko für kardiovaskuläre Erkrankungen", erklärte William B. White, MD, FASH, FAHA, FACP, leitender Forscher der EXAMINE-Studie. „Aufgrund der Auslegung der EXAMINE-Studie und der behandelten Hochrisiko-Patienten liefern diese Ergebnisse Klinikern, die Diabetespatienten mit Koronarerkrankungen behandeln, wertvolle Einblicke."

Die globale EXAMINE-Studie ist von Bedeutung, da sie die kardiovaskuläre Sicherheit bei Patienten mit erhöhtem Risiko für kardiovaskuläre Erkrankungen (KVE) ermittelt. KVE sind die Hauptursache für Morbidität und Mortalität bei Patienten mit Typ-2-Diabetes.

Es wurden insgesamt 5.380 Patienten zwischen 18 und 40 Monate nachbeobachtet. Die Anzahl an vorzeitigen Studienabbrüchen in beiden Gruppen war ähnlich. Die Patienten erhielten auch eine umfassende Standardtherapie für Diabetes Typ 2 und begleitende kardiovaskuläre Risikofaktoren.

„Das Design der EXAMINE-Studie und vor allem die gemessenen Ergebnisse machen diese Studie besonders interessant für die Diabetesbehandlung von Patienten mit hohem Risiko", sagte Ajay Ahuja, MD, Vice President, Global Medical Affairs, Takeda. „Im Laufe der vergangenen 20 Jahre hat Takeda eine solide Expertise für die Diabetesbehandlung aufgebaut und diese stets erweitert. EXAMINE zeigt unser anhaltendes Engagement für die Entwicklung neuer Produkte wie Alogliptin und für eine optimierte Behandlung des Diabetes Typ 2."

Der wichtigste sekundäre Endpunkt bestand aus den Komponenten des prim
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SOURCE Takeda Pharmaceutical Company Limited
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